Want to look young again? A “yes” answer is a no-brainer, but the safety of one popular wrinkle-reduction method is now being questioned. Earlier this year, the Food and Drug Administration (FDA) announced that it had opened an inquiry into the safety of Botox-type products - Botox by Allergan and Myobloc, manufactured by San Diego-based Solstice Neurosciences – after reports of complications and possibly as many as 16 product-related deaths. Some cases involve children with cerebral palsy who were treated with the drugs for muscle spasms, a use which has not yet been approved by the FDA.

After Viagra, Botox is the most recognized prescription drug in the world. Derived from one of several types of botulinum toxins – purified botulinum toxin A – it can paralyze muscles, including those that power the lungs. (The clostridium botulinum bacteria is the same bug that causes food poisoning when contaminated food is eaten.)

The FDA approved Botox in 2002 as a temporary treatment for moderate to severe frown lines between the eyebrows. While this is it’s only “official” use, Botox is also commonly applied to smooth out crow’s feet, creased foreheads and necks. Using Botox is not recommended for erasing lines around the mouth because it could freeze mouth muscles that are needed for eating and talking – and drooling and garbling words wouldn’t exactly be desirable side effects.

Myobloc, a purified form of botulinum toxin B, was approved in 2001 to treat patients with cervical dystonia, a condition that causes severe neck spasms and pain. But Myobloc, like Botox, is also used off-label (not an FDA-approved use) to treat facial lines.

How Botox WorksBotox works by paralyzing specific facial muscles. When the muscle can’t contract, the skin doesn’t wrinkle as much. To smooth lines, wrinkles, and furrows, a doctor uses a thin needle to inject tiny amounts of Botox into the muscles around the eyes and brows. The number of injections depends on the extent and location of the wrinkles. Crow’s feet, for instance, may require two to five injections per eye, forehead furrows six or more. (See related article: 5 Telltale Signs of Aging)

The procedure requires no anesthesia, is typically done in a doctor’s office and takes only about 10 to 15 minutes. Most patients describe the discomfort as tolerable and are able to return immediately to normal activities, although it’s not unusual to have a headache for a few hours. Patients should not massage or rub the treated areas; this may cause the toxin to spread to other areas of the facial muscles, which could result in temporary facial weakness or drooping eyelids.

Within a few hours of the drug being injected, the affected muscles become weaker or completely paralyzed. Most people notice results in a few days, but the full effect typically takes about two weeks to appear. To stay wrinkle-free, patients have to repeat the process every few months. And the cost can quickly add up to big Botox bucks: the price of each treatment is usually between $300 and $500.

Botox is not a face-lift in a vial, and it won’t remove all lines and wrinkles or reverse sun damage. It is primarily intended for removing furrows between the eyebrows. And although it may lessen fine lines and wrinkles, if it’s baby smooth skin you’re after, you may need additional cosmetic procedures such as chemical peels, dermabrasion and laser skin treatments.

Many people have their first close encounter with Botox at a “Botox party,” where a physician or nurse may treat several people in a social setting, often at someone’s home. But always keep in mind that Botox is a drug, not a cosmetic, and injecting a drug derived from a dangerous toxin should be done by a doctor in a medical setting. The FDA has issued warnings about the possible hazards of Botox parties. Most notably, drinking alcohol at Botox parties can lead to bruising more easily after the injections. (See related article: What Your Plastic Surgeon Won’t Tell You)

Although the risk of a reaction is low, emergency equipment should be on hand. Moreover, vials of the drug should not be shared, but this is often common practice common at Botox parties. Botox comes as a powder in a single-use vial. Because the drug is reconstituted with a fluid that contains no preservative, once the vial is open it must be refrigerated and used within four hours. Any excess should be discarded, not frozen.

Botox should not be used if you are pregnant or think you might be pregnant. And you should not be injected if you are breastfeeding; infants are extremely sensitive to the toxin. Certain prescription medications may also interfere with Botox, including antibiotics such as gentamicin, tobramycin, clindamycin, and lincomycin. Other interactions may occur with quinidine-type drugs that are used to treat heart rhythm conditions and medicines used to treat myasthenia gravis (a muscle-weakening condition) and Alzheimer’s disease.

The Botox Safety RecordAccording to Allergan, the pharmaceutical company that makes Botox, no reported deaths have been linked to the use of Botox for cosmetic purposes. The most serious cases investigated by the FDA have occurred among patients using high doses of the drug as neuromuscular treatments. (Patients taking Botox for cerebral palsy-related muscle spasms receive as much as 700 units of the drug, about 28 times the dose commonly used for cosmetic reasons.)

Botox has been used worldwide for more than 18 years and is considered safe when used by trained professionals and applied in methods approved by the FDA. And it is not used only for cosmetic purposes. Some lesser known, FDA-approved uses include the treatment of crossed eyes, uncontrollable blinking, excessive underarm sweating and a number of neuromuscular disorders that cause muscle spasms.

Researchers are currently testing Botox to use for other medical conditions, including the treatment of migraines, muscle spasms following strokes and overactive bladders. And treating new facial scars with Botox may improve their appearance, although this use has not yet been granted FDA approval.

Side effects from Botox include droopy eyelids that can last for several weeks, difficulty swallowing and flu-like symptoms such as a headache and upset stomach. The risk of Botox-related botulism poisoning is low, but large doses in children and adults with certain medical conditions can lead to serious complications, including being unable to breathe.

Another risk is linked to the ease with which people can order Botox on the Internet; in fact, Botox-like products offered on the Internet have caused great harm. In one case, a 34-year-old woman bought research-grade botulinum toxin on the Internet and was injected by a friend. Two days later she developed difficulty swallowing, shortness of breath, double vision and generalized weakness. By the time she was seen by a doctor, she was totally paralyzed. She had received 2000 to 5000 times the amount usually injected for cosmetic procedures. Ten months after she was hospitalized, she still had problems with shortness of breath and overall weakness.

So far, children with cerebral palsy have demonstrated the most serious side effects. Treatment of cerebral palsy typically involves large doses of Botox. So far, FDA concerns tend to focus more on medical than cosmetic uses of the product.

Decision Time Checklist

If the potential dangers don’t deter your decision to try Botox, increase your odds of safety and a successful procedure by doing the following:

· Check out your doctor. Makes sure he or she is board-certified, and that he or she has extensive experience treating people with Botox.

· Have your doctor check you out. A responsible doctor will evaluate you and your medical history before agreeing to give you Botox.

· Check up on risks. Ask your doctor to explain what you should expect, with regard to benefits, risks, interaction with other medications and side effects.

· Check your drink at the door. As mentioned earlier, you should not drink alcohol before or after the time you’re having Botox injections.

· Don’t party on. Getting Botox is no time for a party. Have the procedure done in a medical setting.

What's Your Cosmetic Procedures IQ?Feel like getting "freshened up"? More people are opting for cosmetics procedures to take years off their appearance. From lasers to tummy tucks and microdermabrasion, there's a dizzying array of options. But how much do you really know about this growing industry? Take this cosmetic procedure quiz to find out.

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